TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER F - BIOLOGICS

PART 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS

subpart g - LABELING STANDARDS

610.61 - Package label.

The following items shall appear on the label affixed to each package containing a product: (a) The proper name of the product; (b) The name, address, and license number of manufacturer; (c) The lot number or other lot identification; (d) The expiration date; (e) The preservative used and its concentration, or if no preservative is used and the absence of a preservative is a safety factor, the words no preservative; (f) The number of containers, if more than one; (g) The amount of product in the container expressed as (1) the number of doses, (2) volume, (3) units of potency, (4) weight, (5) equivalent volume (for dried product to be reconstituted), or (6) such combination of the foregoing as needed for an accurate description of the contents, whichever is applicable; (h) The recommended storage temperature; (i) The words Shake Well, Do not Freeze or the equivalent, as well as other instructions, when indicated by the character of the product; (j) The recommended individual dose if the enclosed container(s) is a multiple-dose container; (k) The route of administration recommended, or reference to such directions in an enclosed circular; (l) Known sensitizing substances, or reference to an enclosed circular containing appropriate information; (m) The type and calculated amount of antibiotics added during manufacture; (n) The inactive ingredients when a safety factor, or reference to an enclosed circular containing appropriate information; (o) The adjuvant, if present; (p) The source of the product when a factor in safe administration; (q) The identity of each microorganism used in manufacture, and, where applicable, the production medium and the method of inactivation, or reference to an enclosed circular containing appropriate information; (r) Minimum potency of product expressed in terms of official standard of potency or, if potency is a factor and no U.S. standard of potency has been prescribed, the words No U.S. standard of potency.

  (s) The statement: Rx only for prescription biologicals.

[38 FR 32056, Nov. 20, 1973, as amended at 47 FR 22518, May 25, 1982; 55 FR 10423, Mar. 21, 1990; 67 FR 4907, Feb. 1, 2002]